Prometheus and Patentable Subject Matter Under 35 U.S.C. ' 101

It was reported that, during the argument, Judge Kimberly A. Moore noted that there had been 35 years of granting patents under the understanding that genes are patentable subject matter, and that an entire industry had developed in reliance on the patentability of genes. It remains to be seen whether the Federal Circuit will side with the USPTO's position, and whether the Supreme Court will eventually provide a definitive decision on the issue.

Laural Boone, Ph.D., is a senior associate in the Hogan Lovells New York office. Her practice focuses on litigation.

The recent protracted dispute between Prometheus Laboratories (“Prometheus”) and Mayo Collaborative Services (“Mayo”) has shed some light on the post-Bilski threshold for patent eligibility under 35 U.S.C. ' 101. The first requirement for U.S. utility patents is of course that the claimed invention must fall within the purview of ' 101, i.e., it must be a “new and useful process, machine, manufacture, or composition of matter,” or a “new and useful improvement thereof.” 35 U.S.C. ' 101. These expansive categories are not, however, without limit. Patent protection is not available for laws of nature, physical phenomena, abstract ideas, and mere algorithms. Recent cases have questioned ' 101 patent eligibility in such varied fields as hedge fund management, business methods, methods of treatment, isolated human genes, and biological assays. One example, in the therapeutic treatment field, concerns the Prometheus-Mayo dispute. It was litigated from the California district court all the way up to the Supreme Court, and was decided by the Federal Circuit twice.

Prometheus in the District Court

Prometheus first sued Mayo for infringement of two patents in the U.S. District Court for the Southern District of California. Prometheus Labs., Inc. v. Mayo Collaborative Services, et al., 2008 WL 878910 (S.D. Cal.) Prometheus asserted U.S. Patent Nos. 6,355,623 and 6,680,302. The claims are directed to “method[s] of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder” and to “method[s] of optimizing therapeutic efficacy and reducing toxicity associated with treatment of an immune-mediated gastrointestinal disorder” by determining the level of two specific metabolites so that it “indicates a need” that an adjustment in drug dosage may be required at particular numeric levels. Id. at *1. Mayo had announced that it would begin using a test which utilized the same metabolites but with different numeric levels. Id. On summary judgment, the California court determined that Prometheus' claims were not directed to patentable subject material under ' 101, and granted summary judgment of invalidity. Id. at *14. The California court reasoned that the correlations between drug metabolite levels and therapeutic efficacy and toxicity were natural phenomena and thus unpatentable, citing Judge Stephen Breyer's dissent from the dismissal of certiorari in Laboratory Corporation of America Holdings v. Metabolite, Inc. , 548 U.S. 124 (2006) (“ Lab. Corp. Dissent”). The California court's analysis hinged on the determination that the method steps were “merely necessary data-gathering steps” combined with an additional mental step and thus were a recitation of natural phenomena. Id. at *5-7.

Prometheus at the Federal Circuit

On appeal, the Federal Circuit reversed, articulating that under the “definitive test” for determining process patentability under ' 101, the machine-or-transformation test, the claims were in fact patent eligible. Prometheus Labs., Inc. v. Mayo Collaborative Services , 581 F.3d 1336 (Fed. Cir. 2009) (rehearing en banc denied). The Federal Circuit reasoned that the steps of administering and determining were transformative, and thus were patent eligible, and reversed and remanded the California court's decision. Id. at 1350. Mayo petitioned for certiorari to the U.S. Supreme Court.

The Supreme Court Vacates Prometheus

The Supreme Court decided the 2010 Bilski case on June 28, 2010, establishing that the machine-or-transformation test articulated by the Federal Circuit was not the sole test for determining patent eligibility. In Bilski, the claims of the patent at issue were directed to hedging risk in commodities trading. The Court found these claims to be directed to an abstract idea and, thus, unpatentable. Bilski v. Kappos , 130 S.Ct. 3218 (2010). The Court granted Mayo's petition for certiorari on the day after Bilski was decided and, at the same time, issued a one-paragraph decision vacating the first Federal Circuit Prometheus decision and remanding the case to the Federal Circuit “for further consideration in light of” Bilski . Mayo Collaborative Services v. Prometheus Laboratories, Inc. , 130 S.Ct. 3543 (2010).

The Federal Circuit and Prometheus in View of Bilski

In response, the Federal Circuit largely reiterated its first decision, again finding Prometheus' process claims patent eligible. Prometheus Laboratories, Inc. v. Mayo Collaborative Services et al., 628 F.3d 1347 (Fed. Cir. 2010) (“Prometheus II“). The Federal Circuit held that Prometheus' method claims “recite[d] a patent-eligible application of naturally occurring correlations between metabolite levels and efficiency or toxicity.” Id. at 1355. This time, the Federal Circuit related its analyses to earlier Supreme Court cases. In particular, the Federal Circuit noted that Prometheus' method claims were drawn to a particular application of a natural phenomenon and were thus patentable, citing to the Supreme Court's analysis of the Diehr case in Bilski. Id. at 1354, citing Diamond v. Diehr , 101 S.Ct. 1048 (1981). Diehr claimed a method of curing rubber, using a mathematical formula to complete certain process steps on a computer. Diehr, 101 S.Ct. at 1048. The Diehr claims were found to be patent eligible, despite part of the process being an algorithm, because the invention when considered as a whole was described as “an application of a law of nature.” Id. at 1048 (emphasis added). The Federal Circuit also noted that the Prometheus methods did not “wholly preempt all uses of the recited correlations,” and similarly to Diehr they used a natural correlation but did not seek to pre-empt use of that correlation entirely. Prometheus, 628 F.3d at 1355. The Federal Circuit in a footnote dismissed Mayo's and the California court's reliance on Justice Breyer's Lab. Corp. dissent, noting “[w]ith respect, we decline to discuss a dissent; it is not controlling law and it involved different claims from the ones at issue here.” Prometheus II at n.2.

Lab. Corp. Was Only a Dissent

The disposition of Metabolite's process claim in the Lab. Corp. litigation illustrates some of the tension under ' 101. Lab. Corp. Dissent. Claim 13 of Metabolite's U.S. Patent No. 4,940,658 reads:

13. A method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of: assaying a body fluid for an elevated level of total homocysteine; and correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate.

The claimed method has only two steps. The process requires measuring the levels of the amino acid homocysteine and correlating an elevated level of homocysteine with a deficiency of two vitamins. The claim was found to be patent eligible by both the District Court of Colorado (the jury found Lab. Corp. was responsible for contributory and induced infringement) and the Federal Circuit ( Metabolite Laboratories, Inc. v. Laboratory Corp. of America Holdings , 370 F.3d 1354 (Fed. Cir. 2004). On certiorari, the Supreme Court was asked whether the claim improperly “claim[s] a monopoly over a basic scientific relationship.” Lab. Corp. Dissent at 125 (quoting the petition for certiorari). In Lab. Corp., the Supreme Court initially granted certiorari, but subsequently changed course after hearing oral argument and receiving 20 amici briefs. The Supreme Court dismissed the grant of certiorari without additional elaboration as “improvidently granted.” Lab. Corp. Dissent at 125.

In Lab. Corp., three justices dissented in a 15-page dissent that garnered intense interest among the patent bar. Justice Breyer wrote the dissent, with Justice John Paul Stevens and Justice David Souter concurring. The dissent made clear that these three justices would have taken the case and found the claim invalid. Judge Breyer stated “Claim 13 [ ] covered every homocysteine test that a doctor reviewed” and that “[t]here can be little doubt that the correlation between homocysteine and vitamin deficiency set forth in claim 13 is a 'natural phenomenon.'” Lab. Corp. Dissent at 130, 134 (emphasis in original).

Where Will ' 101 Go Next? Myriad Genetics

Most recently, ' 101 has been implicated in Association for Molecular Pathology v. USPTO , 702 F.Supp.2d 181 (S.D.N.Y. 2010), which concerns the patent eligibility of isolated human genes related to breast cancer detection and screening (BRCA1 and BRCA2, see www.cancer.gov/cancertopics/factsheet/Risk/BRCA). There, the district court held Myriad's patent claims invalid as not covering patentable subject matter. Myriad's patent claims certain isolated human DNA sequences which are genetic markers, but the district court held that only unpatentable naturally occurring subject matter was claimed. Judge Robert W. Sweet of the Southern District of New York, in a lengthy decision, broke with the USPTO's established position that isolated DNA segments are patentable, stating: “the patents at issue directed to 'isolated DNA' containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable subject matter under 35 U.S.C. '101.” Association for Molecular Pathology, 702 F.Supp.2d 181, 185 (S.D.N.Y. 2010). Oral argument on Myriad's appeal was heard by the Federal Circuit on April 4, 2011.

It was reported that, during the argument, Judge Kimberly A. Moore noted that there had been 35 years of granting patents under the understanding that genes are patentable subject matter, and that an entire industry had developed in reliance on the patentability of genes. It remains to be seen whether the Federal Circuit will side with the USPTO's position, and whether the Supreme Court will eventually provide a definitive decision on the issue.

Laural Boone, Ph.D., is a senior associate in the Hogan Lovells New York office. Her practice focuses on litigation.